EP0370890A1 - Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat protection means preferably comprising means forming radioreflecting screen - Google Patents
Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat protection means preferably comprising means forming radioreflecting screen Download PDFInfo
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- EP0370890A1 EP0370890A1 EP89403199A EP89403199A EP0370890A1 EP 0370890 A1 EP0370890 A1 EP 0370890A1 EP 89403199 A EP89403199 A EP 89403199A EP 89403199 A EP89403199 A EP 89403199A EP 0370890 A1 EP0370890 A1 EP 0370890A1
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- Prior art keywords
- probe means
- probe
- screen
- forming
- radioreflecting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/01—Devices for producing movement of radiation source during therapy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/02—Radiation therapy using microwaves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
-
- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00084—Temperature
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22057—Optical properties
- A61B2017/22058—Optical properties reflective
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- A—HUMAN NECESSITIES
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
- A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
- A61B2018/00023—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids closed, i.e. without wound contact by the fluid
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- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00059—Material properties
- A61B2018/00089—Thermal conductivity
- A61B2018/00101—Thermal conductivity low, i.e. thermally insulating
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- A61B2018/00166—Multiple lumina
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- A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
- A61B2018/0022—Balloons
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- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00547—Prostate
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- A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
- A61B2018/183—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves characterised by the type of antenna
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- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
- A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
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- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
- A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
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- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3933—Liquid markers
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- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Definitions
- the present invention relates to an apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat-protection means preferably comprising means forming radioreflecting screen.
- European Patent 0 248 758 describes a microwave applicator which is inserted in the rectum for treating the prostate by hyperthermia.
- the microwave applicator is kept in position inside the rectum by a laterally projecting balloon 7, meaning that special protection of the rectum is required.
- means 52 are provided for reflecting the emitted microwaves which are then concentrated at the side of the body opening opposite to the balloon 7.
- Ducts 28 are provided in the microwave emitting rectal applicator for circulating a cooling liquid, as shown in Figures 2 to 4.
- the cooling liquid protects the rectal walls in contact with the microwave antenna from damage. Moreover, the presence of the reflecting means 52 is absolutely necessary to prevent the antenna from emitting in all directions, when the radiation is only required to be directed onto the prostate tissues.
- European Patent 0 246 176 describes a catheter having an antenna equipped with a temperature sensor which is inserted into the urethra through to the bladder, for locating and determining the position of the microwave applicator described in the above-cited European Patent 0 248 558.
- European Patent 0 105 677 describes such a microwave antenna device for hyperthermia therapy, designed to be introduced in the tract or the lumen, in which device the antenna assembly is placed inside a thin supple polymer film, without any means of protecting the sensitive tissues from the heat.
- Patent document WO-A-81/03616 to Bircher describes yet again a microwave antenna system for hyperthermia therapy, which is inserted in a body cavity and used in the treatment of cancer and similar. Typical examples of inserting apertures are the mouth and upper throat.
- the characteristic of this irradiation treatment is that it is carried out at a lower frequency and at a higher wavelength to improve penetration into the tissues to depths of 5 to 6 cm. Such deep penetration permits extensive irradiation of large tumors in the bowels or similar.
- Tests have been carried out with the same antenna in various media, as reported in Figure 5.
- the medium was a saline solution, and it is underlined in the "Discussion" part that when the medium is changed from air to a conductive medium such as a saline or bile medium, the performances decrease dramatically, which rather discourages the specialist from using a saline solution in microwave-induced hyperthermia.
- the object of the present invention is therefore to solve this new technical problem, particularly in the hyperthermia treatment of the prostate without the need to use special probe means emitting in only one direction.
- Another object of the invention is to solve the aforesaid new technical problems in an extremely simple way, using means for readily and reliably locating the position of the emitting probe means.
- Yet another object of the invention is to solve the aforesaid new technical problems in a semi-invasive way, namely by using the natural body cavities.
- the invention therefore provides an apparatus for the surgical treatment of tissues by hyperthermia, particularly the prostate, of the type comprising heating means for inducing hyperthermia comprising a microwave generating device placed in an emitting probe means adapted to be inserted in a cavity of the body, wherein means are provided for protecting from the heat the sensitive tissues other than the tissues to be treated, preferably comprising means forming radioreflecting screen.
- the means which, according to the invention, form radioreflecting screen contain a radioreflecting liquid medium.
- said radioreflecting liquid medium is an electrically conductive liquid reflecting the microwaves.
- the radioreflecting screen-forming means according to the invention comprise at least one wire, parallel to the mean electrical field.
- the apparatus according to the invention is characterized in that the probe means is a urethral probe means inserted in the urethra up to the level of the prostate.
- the means forming radioreflecting screen according to the invention is at the level of an organ to be treated, such as the bladder, the sphincter.
- said means forming radioreflecting screen and protecting the bladder may comprise a balloon provided on the front end of the antenna, means being provided for filling said balloon with a radioreflecting conductive solution.
- the screen-forming means protecting the bladder comprise a conductive solution injected directly into the bladder, said solution being preferably hypertonic.
- another part of said screen-forming means is fast with a rectal probe means, for protecting the rectal wall from high temperatures.
- said means can comprise a radioreflecting liquid medium, in particular one introduced into a balloon provided around the front end of the rectal probe means.
- the apparatus is characterized in that it further comprises means of controlling the positioning of the urethral probe means, preferably incorporated in a rectal probe means, said rectal probe means serving thus as a protection for the rectal walls and as a means of controlling the positioning of the microwave-emitting urethral probe means in axial position.
- Means of immobilizing the rectal probe means in axial position can be provided, said means preferably permitting a rotation of said probe means around its axis.
- Said immobilizing means preferably comprise a balloon, for example in latex, which surrounds the rectal probe means, and inside which said probe means can be readily oriented from the outside.
- the apparatus is equipped with means for cooling the surface of the emitting probe means, in order to prevent burns on the walls in contact with the probe means, particularly the urethral walls.
- the apparatus according to the invention is characterized in that it comprises temperature sensing means provided on or in the emitting probe means, and/or on or in the rectal probe means and optionally in said balloon.
- said microwave generating device comprises a metallic cable coaxial to the probe means covered by an insulating sleeve over part of its length, said cable also having a microwave-emitting part which is non-insulated, which part is preferably situated at an intermediate or distal level of the emitting probe means.
- said temperature sensing means comprise a fiber-optic thermometer, heat-insulated from the cooling circuit, preferably comprising several strands of fibers disposed in radially and/or longitudinally offset fashion in the longitudinal direction of the probe means, in such a way as to detect the temperature in various radial and/or longitudinal directions of the probe means.
- the emitting probe means can be positioned with great accuracy since it is inserted directly into the prostate along the natural urethral passage, thus preventing the sphincter from being damaged.
- radioreflecting screen-forming means it becomes possible to protect efficiently the bladder as well as the rectal walls.
- an emitting probe means emitting in all directions, but naturally, according to the invention, it is possible, and in some cases advisable or advantageous, to use a probe means emitting preferably in one given direction.
- this shows an apparatus according to the invention, bearing the general reference number 10, for the surgical treatment of tissues 12 by hyperthermia, preferably the prostate 14, of the type comprising heating means 16 for inducing hyperthermia, consisting of a microwave-generating device 18, clearly shown in Figure 2, placed in an emitting probe means of general reference number 20, shown in longitudinal axial section in Figure 2, adapted to be inserted in a cavity of the body.
- heating means 16 for inducing hyperthermia consisting of a microwave-generating device 18, clearly shown in Figure 2, placed in an emitting probe means of general reference number 20, shown in longitudinal axial section in Figure 2, adapted to be inserted in a cavity of the body.
- the emitting probe means 20 is, according to the invention, a urethral probe means.
- the apparatus according to the invention is characterized in that it comprises heat protecting means 22, 30 for protecting the sensitive tissues other than the tissues 12 to be destroyed, such as the prostate 14, said means preferably comprising means forming radioreflecting screen 22, 30.
- the means forming radioreflecting screen comprise a radioreflecting liquid medium, preferably an electrically conductive medium able to reflect the microwaves emitted by the emitting probe means 20 equipped with the microwave emitting device 18.
- said radioreflecting conductive solution is injected directly into the patient's bladder 24.
- said solution is preferably hypertonic. It can be, for example, a solution with a high ion concentration, such as by using NaCl.
- suitable conductive solutions are saturated ionic solutions, such as NaCl or nitrate solutions, said solutions are obvious to anyone skilled in the art.
- one part 22 of the screen forming means is placed level with an organ to be protected, in particular the bladder.
- said means forming protection screen for the bladder comprise a balloon 26 provided on the front end 20a of the probe means 20.
- Said balloon 26 is equipped with means 28 for filling it, preferably with a radioreflecting conductive solution 23.
- Said filling means normally comprise an internal duct 29 extending out towards a flexible tube 30.
- Said radioreflecting conductive solution may be identical to the previous one and based on saturated NaCl solution.
- said probe means comprises cooling means 32 incorporated to the probe means 20 for lowering the temperature of the external wall of said probe means 20, namely, in the illustrated case, the walls of the urethra 34.
- Said cooling means 32 consists, for example, in at least two conduits, respectively an inlet conduit 36 and an outlet conduit 38, containing the cooling medium and communicating with each other at the front of the probe means 20 via a connection conduit 37 clearly shown in Figure 2.
- Said conduits 36, 38 communicate with flexible tubes 40, 42, respectively a supply tube and a discharge tube for the cooling medium, which may be water.
- the urethral emitting probe means 20 is equipped with means 44 for sensing the temperature on or inside the urethral probe means 20.
- said temperature sensor 44 comprises a fiber-optic thermometer 46, the optical fibers being isolated by heat-insulating means 48 from the rest of the probe means and in particular from the cooling circuit 36, 38, as illustrated in Figures 2a and 3.
- Said thermometer comprises a plurality of strands of fibers placed in radially and/or longitudinally offset fashion in the longitudinal direction of the probe means 20, in such a way as to detect the temperature in various radial and/or longitudinal positions of the probe means.
- thermometer 46 and associated insulating means 48 may be disposed in a longitudinal slot 50 provided in the external surface 21 of the probe means 20.
- the front end 20a of the probe means 20 should be rounded to facilitate insertion of the probe means 20 through the urethra and up to the level of the bladder 24, as can be seen in Figure 1.
- the microwave generating device 16 comprises a metallic cable 52 coaxial to the probe means 20 and covered with an insulating sleeve 54 over part of its length, said cable 52 comprising at least one microwave-emitting non-insulated part 52a preferably situated at an intermediate or distal level of the emitting probe means, as clearly illustrated in Figures 2 and 3.
- the free end of the cable 52a forming microwave emitting antenna ends up under the balloon 26 forming the means protecting the bladder.
- Said cable 52 forms an emitting antenna which may be for example 20 to 40 mm long and which radiates in all directions about its axis, i.e. over 360°.
- Said emitting antenna 52a constituted by the non-insulated part of the cable 52 is connected to a microwave generator apparatus symbolized by the initials M.W.G., emitting for example at about 915 MHz and of power adjustable up to 50 W or even 100 W.
- the emitting antenna may be rather more complex and comprise shielding portions along the non-insulated part of cable 52, this with a view to preferentially heating certain parts of the prostate.
- Figure 2a shows an axial cross-section of the emitting probe means 20, and illustrates the shape and position of each one of the elements constituting the probe means .
- the conduits 36, 38 containing the cooling medium such as water
- the temperature sensor 44 and the duct 29 supplying the balloon 26 are situated in substantially the same plane passing through the axis of the probe means, hence of the cable 52, whereas the conduits 36, 38 containing the cooling medium are also arranged symmetrically with respect to said plane of symmetry.
- the urethral probe means designated by the general reference 120 comprises an annular duct 136 coaxial to the probe means 120 communicating with a disc-shaped common duct 137 reaching to a central conduit 138 in which is introduced the microwave-emitting device 18.
- FIG 5 shows another embodiment of the internal structure of the probe means, of which the general reference number has, in this example, been increased of 200, giving it the reference 220.
- the inlet conduit 236 supplying the cooling medium occupies an annular sector of the probe means 220
- the outlet conduit 238 discharging the heated cooling medium occupies a complementary annular sector, both annular sectors 236, 238 being separated by longitudinal transversal partitions 239, 241.
- the emitting device 218 is always placed axially with respect to the probe means 220.
- Figure 5 also shows the conduit 229 supplying the inflating medium, such as for example an electrically conductive liquid, to the balloon provided on the front end of the probe means 220, as well as the temperature sensor 244.
- the inflating medium such as for example an electrically conductive liquid
- Figure 6 illustrates another variant of embodiment in which the parts which are identical or have the same function have been given the same reference numbers, further increased by 100.
- four inlet conduits 336 supplying the cooling medium are provided, said conduits occupying annular sectors of the probe means 320 from the periphery 321 to the central longitudinal orifice 353 in which the microwave-emitting device 318 is inserted.
- the remaining sectors comprise corresponding annular conduits 338 for discharging the cooling medium, a conduit 329 being also provided for inflating the balloon, as well as a slot 350 for housing the temperature sensor 344.
- this shows yet another variant of the structure of the probe means of which the reference number has been further increased by 100, making it then 420.
- Four cooling medium inlet sectors 436 are also provided here, said sectors having rounded edges so that the remaining sectors 438 are substantially cross-shaped, which remaining cooling medium outlet sectors may be intercommunicating or not.
- the emitting device 418 is also placed in the axis of the probe means 428.
- the apparatus according to the invention further comprises means 80 for controlling the positioning of the urethral probe means 20, said means 80 being preferably incoporated in a rectal probe means 82.
- Said control means 80 are preferably constituted by an echographic probe 82 of rectal type.
- Said echographic probe is advantageously connected with a screen-equipped echograph 84.
- the echographic probe may be connected with a central control device 86 centralizing all the information and capable of automatically controlling the microwave generator device M.W.G. as a function of the recorded temperature data and of any data which may have been programmed by the practitioner, as can be understood from Figure 1.
- the central control device 86 receives all the temperature data centralized in a thermometry device as well as the temperature data from the cooling device supplying the cooling means of the emitting probe means 20; it also gives the instructions necessary to the microwave generating device (M.W.G.) as well as to the cooling device. According to a variant embodiment, it can also receive the data issued from the echographic probe 82 relatively to the position of the emitting probe means 20 in relation to the prostate.
- An intersticial thermometer 100 may also be provided, inserted in the prostate 14, under echographic control, so that when biopsies have to be carried out, it is possible to detect the temperature at which the prostate 14 has been brought by the microwaves emitted by the probe means 20. Such temperature data is of course important to determine the power instructions given by the control device 86 to the microwave generator M.W.G.
- the tissues-protecting means according to the invention may comprise a part 90 fast with the rectal probe means 82, for protecting the rectal wall from high temperatures.
- said screen-forming means 90 fast with the rectal probe means comprise an inflatable element 92 forming balloon fixed around the rectal probe 82 on its front end 82a which element is preferably supplied with a radioreflecting liquid medium 94 through a flexible tube 96 preferably identical to that used for inflating the balloon 26 of the urethral probe means.
- a temperature sensor 98 may be provided inside the balloon 92 for detecting the the temperature at the level of the rectal wall 100 facing the prostate 14, the temperature data recorded by said sensor being transmitted to the thermometry device and to the central control device 86, such as a computer or the like.
- said screen-forming means may comprise at least one wire, parallel to the mean electrical field, which wire is placed preferably in integral fashion with the rectal probe means 82 longitudinally thereto, in the direction of the emitting probe means 20.
- Means may also be provided for protecting the sphincter 15 by a balloon system surrounding the probe means 20 similarly to balloon 26, which system can also be supplied by supply means 30.
- the echographic probe 82 connected with a screen-equipped echograph 84 to control the exact position of the emitting probe means 20 inside the prostate 14 by monitoring the echographic image of the emitting probe means 20 on the screen 84.
- the control device 86 can then trigger manually the control device 86 into operation, for carrying out the hyperthermia treatment, the temperature being controlled inside the prostate 14 as well as in the surrounding tissues, and in particular in the rectum, by the various temperature sensors such as 98, 100.
- the apparatus according to the invention it is also possible with the apparatus according to the invention, to protect efficiently the tissues other than the prostate, by various protection means 22, 90. Furthermore, the presence of the cooling means 32 prevents burns from occurring on the walls in contact with the probe means 20, particularly the walls of the urethra 34.
- the invention also relates to a method for surgically treating tissues 12 by hyperthermia, preferably the prostate 14, of the type using a microwave genarating device 18 provided in an emitting probe means 20 capable of being introduced in a cavity of the body, wherein the sensitive tissues other than the tissues 12 to be treated are protected from the heat preferably by providing means forming radioreflecting screen 22, 90.
- said emitting probe means 20 is inserted in the urethra, said probe means being then a urethral probe means inserted in the urethra as far as the prostate. It is preferably provided that one part 22 of said screen-forming means is placed at the level of an organ to be protected, such as the bladder 24 and/or the sphincter 15.
- the positioning of the urethral probe means 20 in relation to the prostate 14 is controlled by inserting a probe means 82 in the rectum, said probe means being of course a rectal probe means.
- a protection forming radioreflecting means is also provided for protecting the rectal wall 100 from high temperatures.
- the total duration of a treatment of the prostate by hyperthermia is normally about 1 hour.
- the emitting probe means can for example emit microwaves at a frequency of about 900 MHz and at a power which can be adjusted up to 50 W or even 100 W.
- the length of the actual emitting antenna is for example between 20 and 40 mm, these values being given by way of indication only.
Abstract
Description
- The present invention relates to an apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat-protection means preferably comprising means forming radioreflecting screen.
- European Patent 0 248 758 describes a microwave applicator which is inserted in the rectum for treating the prostate by hyperthermia. The microwave applicator is kept in position inside the rectum by a laterally projecting balloon 7, meaning that special protection of the rectum is required. Preferably, for heating the prostate, means 52 are provided for reflecting the emitted microwaves which are then concentrated at the side of the body opening opposite to the balloon 7.
Ducts 28 are provided in the microwave emitting rectal applicator for circulating a cooling liquid, as shown in Figures 2 to 4. - The cooling liquid protects the rectal walls in contact with the microwave antenna from damage. Moreover, the presence of the reflecting
means 52 is absolutely necessary to prevent the antenna from emitting in all directions, when the radiation is only required to be directed onto the prostate tissues. - European Patent 0 246 176 describes a catheter having an antenna equipped with a temperature sensor which is inserted into the urethra through to the bladder, for locating and determining the position of the microwave applicator described in the above-cited European Patent 0 248 558.
- From a practical point of view, the design of the microwave applicator described in European Patent 0 248 758 for introduction in the rectum, is not satisfactory in that the application lacks accuracy since the prostate is remotely-irradiated.
- It is furthermore essential with this method to prevent the emission of microwaves in all directions, this implying an emitting antenna of very special design equipped with reflecting means for directing the radiated microwaves in only one direction, namely towards the prostate.
- Finally, and unquestionably, with such a device, it is quite difficult, if not impossible, to protect the sphincter, and more generally to protect the surrounding tissues. This being especially so in the case of bladder treatment.
- European Patent 0 105 677 describes such a microwave antenna device for hyperthermia therapy, designed to be introduced in the tract or the lumen, in which device the antenna assembly is placed inside a thin supple polymer film, without any means of protecting the sensitive tissues from the heat.
- Patent document WO-A-81/03616 to Bircher describes yet again a microwave antenna system for hyperthermia therapy, which is inserted in a body cavity and used in the treatment of cancer and similar. Typical examples of inserting apertures are the mouth and upper throat.
- The introductory part of said patent document cites the document J. Microwave Power 14(2) : 167-171 (1969) relative to an applicator introduced through the rectum for irradiation of the prostate. It is specified that said irradiation treatment involves a burning of the tissues which are close to the electrode.
- According to said document, the characteristic of this irradiation treatment is that it is carried out at a lower frequency and at a higher wavelength to improve penetration into the tissues to depths of 5 to 6 cm. Such deep penetration permits extensive irradiation of large tumors in the bowels or similar.
- The revue "Proceedings of the 13th Annual Northeast Bioengineering Conference, Philadelphia, March 12-13, 1987, pages 390-393, Ryan" describes the pretreating by microwave-induced hyperthermia of patients suffering from biliary obstruction due to cancer, by inserting a catheter into the choledoch to allow drainage in an invasive way.
- Tests have been carried out with the same antenna in various media, as reported in Figure 5. In the case of tests B and D, the medium was a saline solution, and it is underlined in the "Discussion" part that when the medium is changed from air to a conductive medium such as a saline or bile medium, the performances decrease dramatically, which rather discourages the specialist from using a saline solution in microwave-induced hyperthermia.
- It is now the object of the present invention to solve this new technical problem by providing a solution permitting a more accurate surgical treatment of tissues by hyperthermia, in particular the prostate, while efficiently protecting the sensitive tissues other than those to be treated by hyperthermia.
- The object of the present invention is therefore to solve this new technical problem, particularly in the hyperthermia treatment of the prostate without the need to use special probe means emitting in only one direction.
- Another object of the invention is to solve the aforesaid new technical problems in an extremely simple way, using means for readily and reliably locating the position of the emitting probe means.
- Yet another object of the invention is to solve the aforesaid new technical problems in a semi-invasive way, namely by using the natural body cavities.
- All these technical problems are solved for the first time by the present invention, extremely simply, inexpensively, and in a manner exploitable on an industrial scale.
- The invention therefore provides an apparatus for the surgical treatment of tissues by hyperthermia, particularly the prostate, of the type comprising heating means for inducing hyperthermia comprising a microwave generating device placed in an emitting probe means adapted to be inserted in a cavity of the body, wherein means are provided for protecting from the heat the sensitive tissues other than the tissues to be treated, preferably comprising means forming radioreflecting screen.
- According to a particularly advantageous mbodiment of the invention, the means which, according to the invention, form radioreflecting screen, contain a radioreflecting liquid medium. Advantageously, said radioreflecting liquid medium is an electrically conductive liquid reflecting the microwaves.
- According to a variant embodiment, the radioreflecting screen-forming means according to the invention comprise at least one wire, parallel to the mean electrical field.
- According to a currently preferred application to the treatment of the prostate, the apparatus according to the invention is characterized in that the probe means is a urethral probe means inserted in the urethra up to the level of the prostate. Preferably, one part of the means forming radioreflecting screen according to the invention is at the level of an organ to be treated, such as the bladder, the sphincter.
- According to another particularly advantageous embodiment of the invention, said means forming radioreflecting screen and protecting the bladder may comprise a balloon provided on the front end of the antenna, means being provided for filling said balloon with a radioreflecting conductive solution.
- According to a variant embodiment, the screen-forming means protecting the bladder comprise a conductive solution injected directly into the bladder, said solution being preferably hypertonic.
- According to another particularly advantageous embodiment of the invention, another part of said screen-forming means is fast with a rectal probe means, for protecting the rectal wall from high temperatures.
- Thus, according to a variant embodiment of said means forming protection screen for the rectal wall, said means can comprise a radioreflecting liquid medium, in particular one introduced into a balloon provided around the front end of the rectal probe means.
- According to another particularly advantageous embodiment of the invention, the apparatus is characterized in that it further comprises means of controlling the positioning of the urethral probe means, preferably incorporated in a rectal probe means, said rectal probe means serving thus as a protection for the rectal walls and as a means of controlling the positioning of the microwave-emitting urethral probe means in axial position.
- Means of immobilizing the rectal probe means in axial position can be provided, said means preferably permitting a rotation of said probe means around its axis. Said immobilizing means preferably comprise a balloon, for example in latex, which surrounds the rectal probe means, and inside which said probe means can be readily oriented from the outside.
- According to another advantageous embodiment of the invention, the apparatus is equipped with means for cooling the surface of the emitting probe means, in order to prevent burns on the walls in contact with the probe means, particularly the urethral walls.
- According to another variant embodiment, the apparatus according to the invention is characterized in that it comprises temperature sensing means provided on or in the emitting probe means, and/or on or in the rectal probe means and optionally in said balloon.
- According to one particular variant of embodiment, said microwave generating device comprises a metallic cable coaxial to the probe means covered by an insulating sleeve over part of its length, said cable also having a microwave-emitting part which is non-insulated, which part is preferably situated at an intermediate or distal level of the emitting probe means.
- According to yet another particularly advantageous variant of embodiment, said temperature sensing means comprise a fiber-optic thermometer, heat-insulated from the cooling circuit, preferably comprising several strands of fibers disposed in radially and/or longitudinally offset fashion in the longitudinal direction of the probe means, in such a way as to detect the temperature in various radial and/or longitudinal directions of the probe means.
- It is therefore obvious that with the apparatus according to the invention, the emitting probe means can be positioned with great accuracy since it is inserted directly into the prostate along the natural urethral passage, thus preventing the sphincter from being damaged.
- Also, owing to the radioreflecting screen-forming means according to the invention, it becomes possible to protect efficiently the bladder as well as the rectal walls. According to the invention, it is possible to use an emitting probe means emitting in all directions, but naturally, according to the invention, it is possible, and in some cases advisable or advantageous, to use a probe means emitting preferably in one given direction.
- Understandably, therefore, all the decisive technical advantages, unexpected by anyone skilled in the art, and listed hereinabove, are obtained according to the invention, and moreover, the proposed apparatus is very versatile and very easy to handle for a practitioner.
- The invention will be more readily understood on reading the following description of several embodiments of an apparatus according to the invention for the surgical treatment of tissues by hyperthermia, in a preferred application to the treatment of the prostate, reference being made to the accompanying drawings, in which:
- - Figure 1 is a diagrammatical view of a partial section of the complete apparatus according to the invention for the surgical treatment of tissues to be destroyed by hyperthermia, illustrated in its preferred application to the treatment of the prostate, and comprising a urethral emitting probe means and a rectal echographic detecting probe means, both connected to a central control device;
- - Figure 2 is a view showing a partial longitudianl axial section of the main part of the urethral emitting probe means;
- - Figure 2a is a cross-section along line IIa-IIa of Figure 2;
- - Figure 3 is a perspective side view of the urethral emitting probe means shown in Figures 1 and 2, the balloon being deflated;
- - Figure 4 illustrates a variant embodiment of the urethral emitting probe means according to the invention, showing a longitudinal axial section of a second embodiment of the cooling means;
- - Figure 5 illustrates another variant embodiment of the structural design of the urethral emitting probe means, showing an axial cross-section of another embodiment of the cooling means;
- - Figure 6 illustrates another variant of the cooling means in a view similar to Figure 5.
- - Figure 7 illustrates yet another variant embodiment of the cooling means in a view similar to that shown in Figure 5.
- Referring in particular to Figure 1, this shows an apparatus according to the invention, bearing the general reference number 10, for the surgical treatment of tissues 12 by hyperthermia, preferably the prostate 14, of the type comprising heating means 16 for inducing hyperthermia, consisting of a microwave-generating
device 18, clearly shown in Figure 2, placed in an emitting probe means ofgeneral reference number 20, shown in longitudinal axial section in Figure 2, adapted to be inserted in a cavity of the body. - In the preferred example of application of the apparatus to the destruction of the prostate 14 by hyperthermia, illustrated herein, the emitting probe means 20 is, according to the invention, a urethral probe means.
- The apparatus according to the invention is characterized in that it comprises heat protecting
means radioreflecting screen microwave emitting device 18. - According to a particular variant of embodiment, said radioreflecting conductive solution is injected directly into the patient's
bladder 24. In this case, said solution is preferably hypertonic. It can be, for example, a solution with a high ion concentration, such as by using NaCl. In general, suitable conductive solutions are saturated ionic solutions, such as NaCl or nitrate solutions, said solutions are obvious to anyone skilled in the art. - According to another variant of embodiment, one
part 22 of the screen forming means is placed level with an organ to be protected, in particular the bladder. According to a preferred embodiment, said means forming protection screen for the bladder comprise aballoon 26 provided on the front end 20a of the probe means 20. Saidballoon 26 is equipped withmeans 28 for filling it, preferably with a radioreflectingconductive solution 23. Said filling means normally comprise aninternal duct 29 extending out towards aflexible tube 30. Said radioreflecting conductive solution may be identical to the previous one and based on saturated NaCl solution. - According to one advantageous embodiment of the emitting probe means according to the invention, said probe means comprises cooling means 32 incorporated to the probe means 20 for lowering the temperature of the external wall of said probe means 20, namely, in the illustrated case, the walls of the urethra 34. Said cooling means 32 consists, for example, in at least two conduits, respectively an
inlet conduit 36 and anoutlet conduit 38, containing the cooling medium and communicating with each other at the front of the probe means 20 via aconnection conduit 37 clearly shown in Figure 2. Saidconduits flexible tubes - According to another characteristic of the invention, the urethral emitting probe means 20 is equipped with
means 44 for sensing the temperature on or inside the urethral probe means 20. According to an advantageous variant, saidtemperature sensor 44 comprises a fiber-optic thermometer 46, the optical fibers being isolated by heat-insulatingmeans 48 from the rest of the probe means and in particular from the coolingcircuit - Said
thermometer 46 and associated insulatingmeans 48 may be disposed in alongitudinal slot 50 provided in theexternal surface 21 of the probe means 20. - It will be noted that, advantageously, the front end 20a of the probe means 20 should be rounded to facilitate insertion of the probe means 20 through the urethra and up to the level of the
bladder 24, as can be seen in Figure 1. - The
microwave generating device 16, as illustrated in Figures 2 and 3, comprises ametallic cable 52 coaxial to the probe means 20 and covered with an insulatingsleeve 54 over part of its length, saidcable 52 comprising at least one microwave-emittingnon-insulated part 52a preferably situated at an intermediate or distal level of the emitting probe means, as clearly illustrated in Figures 2 and 3. Preferably, the free end of thecable 52a forming microwave emitting antenna ends up under theballoon 26 forming the means protecting the bladder. Saidcable 52 forms an emitting antenna which may be for example 20 to 40 mm long and which radiates in all directions about its axis, i.e. over 360°. - Said emitting
antenna 52a constituted by the non-insulated part of thecable 52 is connected to a microwave generator apparatus symbolized by the initials M.W.G., emitting for example at about 915 MHz and of power adjustable up to 50 W or even 100 W. - According to a variant of embodiment, the emitting antenna may be rather more complex and comprise shielding portions along the non-insulated part of
cable 52, this with a view to preferentially heating certain parts of the prostate. - Figure 2a shows an axial cross-section of the emitting probe means 20, and illustrates the shape and position of each one of the elements constituting the probe means . This figure shows that the
conduits temperature sensor 44 and theduct 29 supplying theballoon 26 are situated in substantially the same plane passing through the axis of the probe means, hence of thecable 52, whereas theconduits - Other variants of structure of the urethral probe means 20 are shown in Figures 4 to 7 in which the same reference numbers increased by 100, are used to designate identical parts or parts having the same function.
- In the embodiment shown in Figure 4, the urethral probe means designated by the
general reference 120 comprises anannular duct 136 coaxial to the probe means 120 communicating with a disc-shapedcommon duct 137 reaching to acentral conduit 138 in which is introduced the microwave-emittingdevice 18. - Referring now to Figure 5, this shows another embodiment of the internal structure of the probe means, of which the general reference number has, in this example, been increased of 200, giving it the
reference 220. As shown in this figure, theinlet conduit 236 supplying the cooling medium, occupies an annular sector of the probe means 220, whereas theoutlet conduit 238 discharging the heated cooling medium, occupies a complementary annular sector, bothannular sectors transversal partitions device 218 is always placed axially with respect to the probe means 220. Figure 5 also shows theconduit 229 supplying the inflating medium, such as for example an electrically conductive liquid, to the balloon provided on the front end of the probe means 220, as well as thetemperature sensor 244. - Figure 6 illustrates another variant of embodiment in which the parts which are identical or have the same function have been given the same reference numbers, further increased by 100. According to said Figure 6, four
inlet conduits 336 supplying the cooling medium are provided, said conduits occupying annular sectors of the probe means 320 from theperiphery 321 to the centrallongitudinal orifice 353 in which the microwave-emittingdevice 318 is inserted. The remaining sectors comprise correspondingannular conduits 338 for discharging the cooling medium, aconduit 329 being also provided for inflating the balloon, as well as aslot 350 for housing thetemperature sensor 344. - Referring to Figure 7, this shows yet another variant of the structure of the probe means of which the reference number has been further increased by 100, making it then 420. Four cooling
medium inlet sectors 436 are also provided here, said sectors having rounded edges so that the remainingsectors 438 are substantially cross-shaped, which remaining cooling medium outlet sectors may be intercommunicating or not. The emittingdevice 418 is also placed in the axis of the probe means 428. - It is therefore understood that various forms of embodiment are possible for the structure of the emitting probe means. The probe means structure such as described and illustrated in Figures 1 through 7, forms an integral part of the invention and is incorporated in the description by way of reference.
- The apparatus according to the invention further comprises means 80 for controlling the positioning of the urethral probe means 20, said means 80 being preferably incoporated in a rectal probe means 82. Said control means 80 are preferably constituted by an
echographic probe 82 of rectal type. Said echographic probe is advantageously connected with a screen-equippedechograph 84. In a variant embodiment, the echographic probe may be connected with acentral control device 86 centralizing all the information and capable of automatically controlling the microwave generator device M.W.G. as a function of the recorded temperature data and of any data which may have been programmed by the practitioner, as can be understood from Figure 1. - The
central control device 86, such as a computer or the like, receives all the temperature data centralized in a thermometry device as well as the temperature data from the cooling device supplying the cooling means of the emitting probe means 20; it also gives the instructions necessary to the microwave generating device (M.W.G.) as well as to the cooling device. According to a variant embodiment, it can also receive the data issued from theechographic probe 82 relatively to the position of the emitting probe means 20 in relation to the prostate. - An
intersticial thermometer 100 may also be provided, inserted in the prostate 14, under echographic control, so that when biopsies have to be carried out, it is possible to detect the temperature at which the prostate 14 has been brought by the microwaves emitted by the probe means 20. Such temperature data is of course important to determine the power instructions given by thecontrol device 86 to the microwave generator M.W.G. - The tissues-protecting means according to the invention may comprise a
part 90 fast with the rectal probe means 82, for protecting the rectal wall from high temperatures. According to a particularly advantageous embodiment, said screen-formingmeans 90 fast with the rectal probe means comprise aninflatable element 92 forming balloon fixed around therectal probe 82 on itsfront end 82a which element is preferably supplied with a radioreflecting liquid medium 94 through aflexible tube 96 preferably identical to that used for inflating theballoon 26 of the urethral probe means. Atemperature sensor 98 may be provided inside theballoon 92 for detecting the the temperature at the level of therectal wall 100 facing the prostate 14, the temperature data recorded by said sensor being transmitted to the thermometry device and to thecentral control device 86, such as a computer or the like. - According to a variant embodiment of the invention, said screen-forming means may comprise at least one wire, parallel to the mean electrical field, which wire is placed preferably in integral fashion with the rectal probe means 82 longitudinally thereto, in the direction of the emitting probe means 20.
- Means may also be provided for protecting the sphincter 15 by a balloon system surrounding the probe means 20 similarly to balloon 26, which system can also be supplied by supply means 30.
- It is obviously possible, according to the invention, to treat efficiently the prostate 14 by hyperthermia, and in general to destroy tissues by hyperthermia.
- It is extremely easy with the
echographic probe 82 connected with a screen-equippedechograph 84 to control the exact position of the emitting probe means 20 inside the prostate 14 by monitoring the echographic image of the emitting probe means 20 on thescreen 84. When the practitioner sees that the emitting probe means is accurately positioned in the prostrate 14, he can then trigger manually thecontrol device 86 into operation, for carrying out the hyperthermia treatment, the temperature being controlled inside the prostate 14 as well as in the surrounding tissues, and in particular in the rectum, by the various temperature sensors such as 98, 100. - It is also possible with the apparatus according to the invention, to protect efficiently the tissues other than the prostate, by various protection means 22, 90. Furthermore, the presence of the cooling means 32 prevents burns from occurring on the walls in contact with the probe means 20, particularly the walls of the urethra 34.
- The invention also relates to a method for surgically treating tissues 12 by hyperthermia, preferably the prostate 14, of the type using a
microwave genarating device 18 provided in an emitting probe means 20 capable of being introduced in a cavity of the body, wherein the sensitive tissues other than the tissues 12 to be treated are protected from the heat preferably by providing means formingradioreflecting screen - According to a variant embodiment of this surgical treatment method, said emitting probe means 20 is inserted in the urethra, said probe means being then a urethral probe means inserted in the urethra as far as the prostate. It is preferably provided that one
part 22 of said screen-forming means is placed at the level of an organ to be protected, such as thebladder 24 and/or the sphincter 15. - According to another advantageous variant of the method of the invention, the positioning of the urethral probe means 20 in relation to the prostate 14 is controlled by inserting a probe means 82 in the rectum, said probe means being of course a rectal probe means. Advantageously, a protection forming radioreflecting means is also provided for protecting the
rectal wall 100 from high temperatures. - Other variant embodiments of the treatment method according to the invention follow from the description given hereinabove with reference to the apparatus.
- By way of indication, the total duration of a treatment of the prostate by hyperthermia is normally about 1 hour. The emitting probe means can for example emit microwaves at a frequency of about 900 MHz and at a power which can be adjusted up to 50 W or even 100 W. The length of the actual emitting antenna is for example between 20 and 40 mm, these values being given by way of indication only.
- Obviously, the invention also extends to any means constituting technical equivalents of the means described herein, as well as to the combination thereof.
Claims (15)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR8815126 | 1988-11-21 | ||
FR8815126A FR2639238B1 (en) | 1988-11-21 | 1988-11-21 | APPARATUS FOR SURGICAL TREATMENT OF TISSUES BY HYPERTHERMIA, PREFERABLY THE PROSTATE, COMPRISING MEANS OF THERMAL PROTECTION COMPRISING PREFERABLY RADIOREFLECTIVE SCREEN MEANS |
CA002031740A CA2031740C (en) | 1988-11-21 | 1990-12-07 | Apparatus for the surgical treatment of tissues by hyperthermia, and in particular the prostate, using a urethral microwave-emitting probe means equipped with heat-protection means |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
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EP91113481A Division EP0459535B1 (en) | 1988-11-21 | 1989-11-21 | Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, with cooling means |
EP91113481.5 Division-Into | 1991-08-12 |
Publications (2)
Publication Number | Publication Date |
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EP0370890A1 true EP0370890A1 (en) | 1990-05-30 |
EP0370890B1 EP0370890B1 (en) | 1995-11-08 |
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ID=25674398
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EP89403199A Revoked EP0370890B1 (en) | 1988-11-21 | 1989-11-21 | Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat protection means preferably comprising means forming radioreflecting screen |
EP91113481A Expired - Lifetime EP0459535B1 (en) | 1988-11-21 | 1989-11-21 | Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, with cooling means |
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Application Number | Title | Priority Date | Filing Date |
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EP91113481A Expired - Lifetime EP0459535B1 (en) | 1988-11-21 | 1989-11-21 | Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, with cooling means |
Country Status (10)
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US (2) | US5234004A (en) |
EP (2) | EP0370890B1 (en) |
JP (1) | JPH02180279A (en) |
KR (1) | KR100190933B1 (en) |
AT (2) | ATE389437T1 (en) |
CA (1) | CA2031740C (en) |
DE (1) | DE68924760T2 (en) |
ES (1) | ES2022063T3 (en) |
FR (1) | FR2639238B1 (en) |
GR (1) | GR3018153T3 (en) |
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Also Published As
Publication number | Publication date |
---|---|
DE68924760T2 (en) | 1996-04-11 |
FR2639238B1 (en) | 1991-02-22 |
DE68924760D1 (en) | 1995-12-14 |
ATE389437T1 (en) | 2008-04-15 |
US5480417A (en) | 1996-01-02 |
ATE129910T1 (en) | 1995-11-15 |
US5234004A (en) | 1993-08-10 |
ES2022063T3 (en) | 1996-10-01 |
ES2022063A4 (en) | 1991-12-01 |
GR3018153T3 (en) | 1996-02-29 |
EP0459535A3 (en) | 1992-01-02 |
KR100190933B1 (en) | 1999-06-01 |
FR2639238A1 (en) | 1990-05-25 |
CA2031740C (en) | 1996-10-15 |
KR920017679A (en) | 1992-10-21 |
CA2031740A1 (en) | 1992-06-08 |
EP0459535B1 (en) | 2008-03-19 |
JPH02180279A (en) | 1990-07-13 |
EP0370890B1 (en) | 1995-11-08 |
EP0459535A2 (en) | 1991-12-04 |
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